| CTRI Number |
CTRI/2026/01/102603 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing the Effectiveness of Lodhradi Syrup for Non-Infective Diarrhea in Infants with compared to Pro-GG Drops. |
|
Scientific Title of Study
|
Evaluation of the Efficacy of Lodhradi Syrup in Atisara (Non-Infective Diarrhea) in Infants: A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tejmala Narayan Kadam |
| Designation |
MD SCHOLAR KAUMARBHRITYA |
| Affiliation |
DR. D. Y. Patil College of Ayurved and Research Centre |
| Address |
OPD NO.1, Department of Kaumarbhritya DR. D. Y. Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9552474954 |
| Fax |
|
| Email |
tejmalakadam1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayatri Khade |
| Designation |
Associate professor, PhD Scholar |
| Affiliation |
DR. D. Y. Patil College of Ayurved and Research Centre |
| Address |
OPD NO.1, Department of Kaumarbhritya DR. D. Y. Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7741044423 |
| Fax |
|
| Email |
gayatri.khade@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Tejmala Narayan Kadam |
| Designation |
MD SCHOLAR KAUMARBHRITYA |
| Affiliation |
DR. D. Y. Patil College of Ayurved and Research Centre |
| Address |
OPD NO.1, Department of Kaumarbhritya DR. D. Y. Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9552474954 |
| Fax |
|
| Email |
tejmalakadam1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tejmala Narayan Kadam |
| Address |
DR. D. Y. Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune 411018,Maharashtra INDIA |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tejmala Narayan Kadam |
DR. D. Y. Patil College of Ayurved and Research Centre |
OPD NO.1,Department of Kaumarbhritya,DR. D. Y. Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune 411018,Maharashtra INDIA.
Pune
MAHARASHTRA |
9552474954
tejmalakadam1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA & RC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K529||Noninfective gastroenteritis and colitis, unspecified. Ayurveda Condition: ATISARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lodhradi Syrup, Reference: Yogratnakar Balchikitsa 441, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 1.4(ml), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Pro-GG Drop | 0.5 mal twice a day for 5 Days orally before meal |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
Patient with 0 to 12 month age group will be selected.
Patient of Non infective diarrhea with no signs of dehydration.
Frequency of motion less than equals to 10 episodes per day.
Patient having classical signs & symptoms of Atisara Non infective Diarrhea.
Drava Malapravrutti Mutrapravrutti Malaswaroop General Appearance
|
|
| ExclusionCriteria |
| Details |
Patient suffering from persistent diarrhea, chronic diarrhea pravahika persistent vomiting
Diarrhea due to any immune deficiency like acquired or congenital.
Patients of some dehydration to severe dehydration
patients suffering from any chronic or systemic illness.
Atisara due to any food poisoning or iatrogenic origin.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in stool frequency within the treatment period in infants diagnosed with Atisara (non-infective diarrhea).
|
0th day 3rd day and 5th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in stool consistency .
Duration of diarrhea until complete recovery .
Safety and tolerability of Lodhradi Syrup .
Any side effect of interventional drug.
|
0th day 3rd day 5th day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to evaluate the efficacy and safety of Lodhradi Syrup in the management of atisara (non-infective diarrhea) in infants. It is designed as a randomized controlled clinical trial to scientifically assess the therapeutic benefits of a classical Ayurvedic formulation in improving stool frequency, consistency, associated symptoms, and overall clinical outcome in infants compaired to ProGG Drop. |